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Wray testified about the matter before the Senate Judiciary Committee last week. R-S. putting the burden on the plaintiff to prove that a statement substantially harmed its reputation. told la Verita newspaper that the new securities could be "spent anywhere, Some of this cognitive dissonance is simply a problem with statistics.Police said surveillance video showed Leritz going in and out of Knowles’ apartment in Park Rapids several times Feb.lang@timemagazine.K. its maker and one of the world’s largest pharmaceutical companies The occasion sparked little drama In the cool refuge of the conference room advisers politely questioned company scientists and complimented their work By day’s end the panel voted seven to one to approve FDA as usual later signed off The drug ticagrelor marketed under the name Brilinta sold rapidly emerging as a billion-dollar blockbuster It cuts risk of death from vascular causes heart attacks and strokes modestly more than its chief competitor—and currently costs 25 times as much Related story FDA headquartered in Silver Spring Maryland uses a well-established system to identify possible conflicts of interest before such advisory panels meet Before the Brilinta vote the agency mentioned no financial conflicts among the voting panelists who included four physicians As Brilinta’s sales took off later however AstraZeneca and firms selling or developing similar cardiovascular therapies showered the four with money for travel and advice For example those companies paid or reimbursed cardiologist Jonathan Halperin of the Icahn School of Medicine at Mount Sinai in New York City more than $200000 for accommodations honoraria and consulting from 2013 to 2016 During that period for example AstraZeneca says it paid Halperin more than $11000 in expenses and fees for work on an advisory board service on a data monitoring committee for a clinical trial of Brilinta led by the University of California San Francisco and for his service chairing the data monitoring committee for an AstraZeneca-sponsored multimillion-dollar clinical trial of Brilinta led by Duke University Brilinta fits a pattern of what might be called pay-later conflicts of interest which have gone largely unnoticed—and entirely unpoliced In examining compensation records from drug companies to physicians who advised FDA on whether to approve 28 psychopharmacologic arthritis and cardiac or renal drugs between 2008 and 2014 Science found widespread after-the-fact payments or research support to panel members The agency’s safeguards against potential conflicts of interest are not designed to prevent such future financial ties Other apparent conflicts may have also slipped by: Science found that at the time of or in the year leading up to the advisory meetings many of those panel members—including Halperin—received payments or other financial support from the drugmaker or key competitors for consulting travel lectures or research FDA did not publicly note those financial ties The analysis which used physician disclosures in freely available publications and Centers for Medicare & Medicaid Services records for 2013 to 2016 on the federal Open Payments website examined direct payments to physicians from firms whose drugs were voted on It also considered payments from competitors selling or researching drugs of the same class or intended for the same condition—because competing drugs might be affected positively or negatively by the market entry of a new contender or by restrictions or warnings placed on a new drug’s label Science further looked at research funding from a company to an FDA adviser directly or through their institution Such money—including "associated research" funding that nearly always supports principal investigators—affects a scientist’s career advancement compensation or professional influence (Check out an interactive that details all of these payments) Among the investigation’s key findings: Varying sums An analysis of pharma payments to 107 physicians who advised FDA on 28 drugs approved from 2008 to 2014 found that a majority later got money for travel or consulting or received research subsidies from the makers of the drugs on which they voted or from competing firms 0 10 20 30 40 50 $1–$10K $100K–$1M No payment $10K–$100K >$1M 41 26 20 14 6 107 advisers 0 10 20 30 Corporate payments and other support given to advisers before a drug review are widely acknowledged as troubling When "a voting member of a committee demonstrably had financial associations with the company or the competitor prior to the meeting and the FDA doesn’t flag it then somebody’s dropping the ball on due diligence" says Yale University physician Robert Steinbrook editor at large for JAMA Internal Medicine Yet benefits that come later even years after a drug approval vote—jobs money professional prestige and influence—are also fraught ethicists say They are a way of "postponing your reward" says Carl Elliott a medical ethicist at the University of Minnesota in Minneapolis who has persistently criticized the financial inducements pharma gives to researchers "You do something positive for a company that you feel confident is going to pay you back for it later on And they do" Vinay Prasad a hematologist-oncologist at Oregon Health & Science University in Portland who has studied financial conflicts in drug approvals is similarly troubled "The people who are asked to weigh this evidence impartially often stand to gain tremendously in their further professional careers from a positive relationship with the company" he says It might not be a "quid pro quo" according to Prasad "but you don’t have to evoke that to be very concerned It’s in their best interest to play nice with these companies" FDA declined interview requests about Science’s findings A spokesperson provided a statement saying people serving on drug approval advisory panels must disclose any "prospective employer" but not anticipated payments The statement further notes that "FDA also screens potential participants for relationships and situations that do not create a financial conflict of interest but that may create the appearance that a committee member lacks impartiality" AstraZeneca spokesperson Karen Birmingham says "we are not aware" of any effort to support advisers after they serve on FDA panels reviewing the company’s drugs "other than the routine involvement in clinical trials or expert panels for which that [adviser] may have been sought independently because of their expertise" Halperin says a direct payment from a drug company for a lecture or consulting "isn’t really very much different than having an insurance company giving you a check for seeing a patient one day It’s the same thing" His 2009 recommendation for Brilinta’s approval he says was not influenced by anticipation of large payments or research funding from AstraZeneca or its competitors And Halperin argues that such relationships may be the price of expertise "It’s probably better to have someone who has some experience in [the specialized topics considered] than a bunch of unconflicted high school students" he says But the cardiologist agrees that expectations of future rewards can promote bias "I share [the] concern that this could lead to people acting in ways that you would not want them to do" Halperin says "We don’t want incentives that are not serving the public interest In my case it’s the patient’s interest" And he notes that some medical organizations have begun to address delayed incentives They ask members who write clinical practice guidelines to avoid financial relationships with affected companies for a period afterward—a tougher standard than what FDA requires for its advisers That solution and others should be up for debate say ethicists and regulatory experts including one prominent former FDA employee "The idea of banning future payments is likely to have a lot of thorny aspects but it’s worth discussing" even at the risk of losing some experts to government service says David Kessler FDA commissioner under former Presidents George H W Bush and Bill Clinton "It’s a balancing act but public trust is paramount" After the Brilinta vote In 2010 FDA advisers voted to recommend approval for Brilinta which helps prevent blood clots in heart-disease patients Four physicians who voted later received funds from AstraZeneca its maker and competing firms for consulting and travel or worked on research underwritten by those companies Competitors FDA advisers Manufacturer Bristol-MyersSquibb Pfizer $231604(JonathanHalperin) $103702 $577077 $88862 Merck Teva AstraZeneca BoehringerIngelheim Johnson & Johnson Amgen The Medicines Co Takeda Astellas Pharma GlaxoSmithKline Daiichi Sankyo Lilly Dr Reddy’sLaboratories $111 Jacob Sitko enlisted in the US Army in January 2008 and gave his heart and soul to it for more than 3 years—for a time serving in Iraq as a Humvee gunner in the infantry In 2011 the private died in bed at his barracks at Fort Carson in Colorado where he was being treated for posttraumatic stress disorder (PTSD) Months later the Army finally gave Sitko’s heart back to his mom Lois Vinall cries softly as she recounts her son’s story Right after his death the Army told her that Sitko who was 21 and in good health other than his PTSD had been killed by "mixed-drug intoxication" Army doctors had been giving him a cocktail of medicines that included quetiapine a top-selling antipsychotic from AstraZeneca sold under the name Seroquel The particular mixture had been linked for years to sudden cardiac death though no evidence has been made public that Sitko was told that "They sent his body home without his heart" and didn’t say why Vinall says "They returned it in a baby coffin to me 3 months later wrapped in green felt" Vinall recently learned that after removing her son’s heart the Army decided not to examine it further She says a military medical examiner told her Sitko’s autopsy hadn’t been correctly "certified" and that her son might have suffered cardiac death Vinall had cremated his body but buried his heart in a veterans’ cemetery in Redding California close to family Two years earlier two panels of FDA advisers had considered whether to approve Seroquel for new conditions—schizophrenia and bipolar disorder in children and depression in adults who are taking other medicines Seroquel was then known to be associated with sudden cardiac death when used with certain drugs and several antipsychotics similar to Seroquel also had a record of cardiac fatalities But AstraZeneca presented results from its clinical studies which company representatives said showed at worst minimal risks In 2009 both panels voted by wide margins to approve Seroquel for the additional conditions In the years afterward several FDA advisers received significant financial support from AstraZeneca and the makers of competing drugs The biggest payments went to Duke cardiologist Christopher Granger who sat on one of the two groups From 2013 to 2016 the period recorded by Open Payments he or Duke on his behalf received more than $63000 from AstraZeneca and $13 million from competitors According to conflict-of-interest disclosures in journal articles on which Granger was an author he received additional unspecified amounts from those companies between 2010 and 2012 Granger says the industry funds solely underwrote research on cardiovascular topics and did not augment his salary But according to the federal data more than $400000—including all of AstraZeneca’s portion—went to him for travel consulting and honoraria "I fully realize that when I’m paid by somebody like every other human being that may affect the way that I think about things So I’m not nave" Granger says But the expectation of future support from the makers of antipsychotics he adds did not influence his assessments of Seroquel or similar drugs Granger says he recommended the drug’s conditional approval after becoming convinced—as were nearly all others on his panel—that Seroquel’s value outweighed its risks for some people with severe psychiatric disabilities The next year in 2010 AstraZeneca paid the government $520 million to settle lawsuits involving alleged improprieties in the company’s clinical trials and improper marketing of Seroquel for unapproved conditions The company which denied wrongdoing pulled in more than $5 billion in revenues from the drug that year In 2011 after mounting evidence of sudden cardiac deaths FDA forced AstraZeneca to add a warning to Seroquel’s label that the drug posed risks of fatal cardiac events when combined with certain other drugs Sitko died 3 weeks later In recent years FDA has fielded thousands of complaints about cardiac problems including many deaths tied to Seroquel Granger calls the drug’s widespread use for unapproved conditions such as insomnia a "public health tragedy" Sitko and many others were given the drug in part to treat insomnia The company has said repeatedly that Seroquel is acceptably safe and effective to treat conditions for which FDA approved it I share [the] concern that this could lead to people acting in ways that you would not want them to do Jonathan Halperin Icahn School of Medicine at Mount Sinai Policing future drug industry payments received by FDA advisory committee members would be challenging even for an agency adept at limiting conflicts of interest Yet Science’s investigation raises questions about how well FDA enforces more traditional conflict rules FDA asks panel members who vote on recommending drug approvals to disclose in advance details of investments contracts or other payments from drugmakers The agency uses those disclosures to determine whether pharma backing during or before a meeting should disqualify an adviser Each adviser must "certify to the truth and completeness of any information provided" according to the FDA statement to Science The agency can issue a waiver to permit participation despite an active conflict or one that ended during the 12 months preceding a meeting if special expertise cannot readily be obtained otherwise That system helps secure researchers with "deep scientific and medical expertise" Kessler a pediatrician and lawyer now at the University of California San Francisco says But the agency’s financial review process is primarily an honor system and seems to miss obvious conflicts For the 17 physicians receiving the most compensation after a drug advisory vote Science examined whether they also received industry compensation concurrent with or shortly before their FDA service Evidence of such payments came from conflict-of-interest statements in journal articles that those authors published near the time of their advisory role Eleven physicians acknowledged support from competing companies on one or more drugs they reviewed Five of those also received such funding from the makers of one or more of the drugs Yet FDA publicly noted none of those apparent conflicts and issued no conflict waivers Science found that AstraZeneca and makers of rival drugs made payments to or funded research by several FDA advisers—including Granger—in the year leading up to the 2009 meetings on Seroquel Granger calls full financial disclosure "crucially important" in order for FDA to assemble the best committee "I certainly hope that I disclosed everything" he says "If I hadn’t I would be horrified because that’s antithetical to everything I believe in" After initially offering to share his disclosure forms Granger did not respond to repeated requests for copies In response to a Freedom of Information Act (FOIA) request FDA says it could not locate his documents Halperin has a similar history In addition to receiving funds from AstraZeneca and its competitors after he voted to approve the anticlotting drug Brilinta Halperin was receiving unspecified payments or research support from rival firms during the 12 months before the meeting He says he disclosed the payments to FDA and that it did not flag them as conflicts Science requested copies of his disclosure materials but Halperin did not provide them Again FDA says it could not locate Halperin’s disclosures "The system is dependent on the truthfulness of the self-reporting of disclosures" says Genevieve Kanter a University of Pennsylvania economist who has studied conflicts of interest in FDA drug evaluations She calls Science’s findings of payments to advisers during the year before a committee meeting "significant" And she added that such payments would be "stunning" if consistently large After the Seroquel vote In 2009 FDA advisers voted to recommend approval of the antipsychotic Seroquel for new indications despite data linking the drug and similar offerings to sudden cardiac death Four physicians who voted later received funds for consulting travel or research from AstraZeneca Seroquel’s maker and its competitors Competitors FDA advisers Manufacturer $14 million(ChristopherGranger) $23487 $5005 $4601 AstraZeneca BoehringerIngelheim Bristol-MyersSquibb GlaxoSmithKline Lilly Johnson & Johnson Takeda AbbVie Otsuka $121505 The journal disclosures don’t specify payment amounts and the Open Payments data cover only a few years making such a pattern impossible to show But an FDA advisory committee that in 2016 voted unanimously to recommend approval of adalimumabatto (Amjevita) Amgen’s immune-altering drug for rheumatoid arthritis serves as one striking example Amjevita which FDA then greenlighted is similar to AbbVie’s blockbuster adalimumab (Humira) and experts believe Amjevita will be a big seller Rheumatologist Daniel Solomon of Harvard Medical School in Boston chaired the Amjevita panel Neither FDA nor Solomon disclosed publicly that about 3 months before that meeting Amgen provided $232000 for his study of etanercept (Enbrel) another arthritis drug made by Amgen and 1 month before the meeting AbbVie provided $819000 for a Solomon study of Humira That support was for "in-kind donations" of drugs "evaluated as part of a NIH-funded research study for which I am one of the principal investigators" Solomon wrote in an email He does not regard them as a conflict with Amjevita’s approval Drug donations a common practice benefit both parties Donated drugs help ensure that leading academic specialists will prioritize a company’s product in major studies that also enhance the researcher’s professional standing and influence Solomon says he described the payments in an FDA disclosure but he hadn’t kept a copy The agency rejected a FOIA request for the document calling its release "a clearly unwarranted invasion of personal privacy" From such responses it’s not clear whether the agency knew about those potential conflicts and if so whether officials decided they didn’t warrant a waiver FDA would not discuss any individual adviser or detail what if anything the agency does to validate advisers’ disclosures Kanter says she favors more research to learn how commonly payments are not disclosed by advisers or by FDA to "give us a sense of whether the agency should do some independent verification" Kessler suggests that greater FDA transparency also could help "Maybe we need to think about whether the process for reviewing conflicts of interest should be done in a more open independent manner than the current black box the agency uses" he says But the former agency head warns that FDA still must find and retain the relatively few specialists "who really can contribute to the issues at hand with exquisite detailed experience" When so many of them take pharma money Kessler adds the agency has to be flexible Halperin—a national leader in cardiology research and practice—puts it bluntly: "The key is disclosure not squeaky cleanness" Yet some ethicists say such arguments are unconvincing if not self-serving The 107 advisers that Science reviewed combined with 11 federal scientists who served on at least one of the 28 review panels and remain with the government suggest that potential conflicts can be avoided and often are Among that group 47 took less than $800 from pharma after their service on the advisory panel Thirty-four took no money at all (Regular federal employees can almost never accept outside compensation) Elliott argues that the prestige and importance of serving on an FDA advisory committee would outweigh the lure of industry financial favors for many more discipline experts if FDA forced them to choose The European Medicines Agency in London the closest analog to FDA does force such choices It has no policy on payments to advisers after serving on a drug advisory panel However it bars advisers who have concurrent financial ties to drug companies whose products are under consideration and it prohibits or strictly limits the participation of advisers whose connections to a company go back at least 3 years before an advisory meeting Disqualifying factors can include speaking fees consulting contracts and research grants—both for scientists conducting industry-sponsored studies and for those like Halperin who work on data monitoring committees The agency investigates financial disclosures on its own initiative or after tips from whistleblowers Given the apparent gaps Science found Kanter says the FDA system for evaluating possible conflicts of interest—hidden from the public and based primarily or completely on adviser disclosures—might be strengthened to guard against the clearest causes of potential bias For example she found that advisory committee members are more likely to vote for a drug’s approval if their financial ties were exclusively to that drug’s maker rather than to several companies Elliott suggests a more radical solution "Even in the best of circumstances disclosure is a remarkably weak way of controlling conflicts of interest" he says "A better way would simply be for the FDA to say ‘We are not taking anybody with any kind of conflict on an advisory committee’" Pick a drug Select a drug to see the payments FDA advisory committee members received from 2013 to 2016 from companies that manufactured the drug or that competed in the same market Hover over a company adviser or link to see payment amount Manufacturer Competitors FDA advisers Story written by Charles Piller Data analysis by Charles Piller and Jia You The methodology and data for this story are available online Meagan Weiland and Katie Langin contributed reporting The story was supported by the Science Fund for Investigative Reporting *Correction 25 September 5:30 pm: Based on information in the Open Payments database this story previously noted a $19 million “associated research” payment by AstraZeneca linked with Jonathan Halperin AstraZeneca now says it submitted incorrect information to the database—instead of two $958012 payments there was single payment of that amount and it should be attributed to scientists at the University of California San Francisco not Halperin AstraZeneca said it is submitting a correction to OpenPayments and the text and graphics above have been updated to reflect the actual payments publicly disclosed from AstraZeneca to Halperin which total $11139 from 2013 to 2016 When initially asked about the $19 million AstraZeneca payment Halperin mistakenly said—and the story reported—that this sum had gone to Duke University for a clinical trial of Brilinta on which he chaired the data monitoring committee That information has been removed from the story ” the FDA said in a statement. diplomats and businessmen.

guns, or they must be released. EST. Paul business community sought to exhibit their city’s martial enthusiasm by organizing patriotic marches and rallies.S.136 percent.